Adjuvant Bleomycin, Etoposide and Cisplatin (BEP) Versus Carboplatin in Stage I Seminomatous Testicular Cancer (SWENOTECA-ABC)
Primary Purpose
Testicular Neoplasms, Seminoma
Status
Recruiting
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Bleomycin Etoposide and Cisplatin
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Testicular Neoplasms focused on measuring Chemotherapy, adjuvant, Recurrence, Carboplatin, Bleomycin, Etoposide, Cisplatin
Eligibility Criteria
Inclusion Criteria:
- Histological diagnosis of unilateral seminoma testicular cancer, evaluating both size of tumor and invasion of the rete testis
- Clinical stage I
- Tumor size over 4 cm and/or stromal invasion of the rete testis by tumor cells
- Normal value of alpha-fetoprotein (AFP) before orchiectomy. A stable, slightly elevated AFP as a normal value may be permitted.
- Age ≥ 18 years and < 60 years
- Adequate organ function defined as:
Serum aspartate transaminase (ALT) ≤ 1.5 x upper limit of normal (ULN). Total serum bilirubin ≤ 1.5 x ULN Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L Creatinine clearance > 50 ml/min (eGFR) All fertile patients should use safe contraception Written informed consent
Exclusion Criteria:
- Signs of metastatic disease evaluated by CT thorax, abdomen and pelvis. Patients in need of restaging (see SWENOTECA IX) should not be included
- Prior diagnosis of testicular cancer
- Chronic pulmonary disorders giving a high risk of bleomycin induced toxicity (for example chronic obstructive pulmonary disease or lung fibrosis)
- Cancer other than seminoma testicular cancer
- Known hypersensitivity or contraindications for the study drugs
- Serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
- Medical, social, psychological conditions that could prevent adequate information and follow-up
Sites / Locations
- Institutt for kreftforskning og molekylær medisin, St Olavs HospitalRecruiting
- St. Olavs University hospital HFRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bleomycin-Etoposide-Cisplatin
Carboplatin
Arm Description
One course of adjuvant BEP.
One course of adjuvant carboplatin AUC7
Outcomes
Primary Outcome Measures
Relapse rate
Secondary Outcome Measures
Full Information
NCT ID
NCT02341989
First Posted
January 14, 2015
Last Updated
July 4, 2023
Sponsor
St. Olavs Hospital
Collaborators
Haukeland University Hospital, University Hospital of North Norway, Sahlgrenska University Hospital, Sweden, Karolinska Institutet, Oslo University Hospital, Uppsala University Hospital, University Hospital, Linkoeping, Skane University Hospital, Norrlands University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02341989
Brief Title
Adjuvant Bleomycin, Etoposide and Cisplatin (BEP) Versus Carboplatin in Stage I Seminomatous Testicular Cancer
Acronym
SWENOTECA-ABC
Official Title
A Randomized Phase III Study Comparing One Course of Adjuvant Bleomycin, Etoposide and Cisplatin (BEP) and One Course of Carboplatin AUC7 in Clinical Stage I Seminomatous Testicular Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2015 (Actual)
Primary Completion Date
December 2035 (Anticipated)
Study Completion Date
December 2035 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Haukeland University Hospital, University Hospital of North Norway, Sahlgrenska University Hospital, Sweden, Karolinska Institutet, Oslo University Hospital, Uppsala University Hospital, University Hospital, Linkoeping, Skane University Hospital, Norrlands University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
One course of adjuvant carboplatin AUC7 is considered internationally to be a standard treatment option in clinical stage I seminoma, regardless of risk factors. Treatment is based on a large, randomized phase III study comparing adjuvant carboplatin with adjuvant radiotherapy. This study was done without registering data on possible risk factor for relapse. The relapse rate following carboplatin was in this study estimated to be 5.3 %. Data from a prospective, risk-adapted Spanish study showed that patients without risk factors had a very low risk of relapse, even without adjuvant treatment. This result is also confirmed by a recent analysis of SWENOTECA VII data, showing that this group of patients has a risk of relapse of less than 5 % without adjuvant treatment.
Combined data from SWENOTECA V and VII studies indicate a high risk of relapse in patients with one or two risk factors (tumor 4 cm, stromal invasion of rete testis) treated with one course of adjuvant carboplatin. The relapse rate in this group of patients was 9.4 %, indicating a very modest effect of one course of adjuvant carboplatin. If adjuvant chemotherapy is the preferred treatment strategy, more potent chemotherapy regimens should be explored in this patient group. The results from SWENOTECA III/VI studies with one course of cisplatin-based adjuvant chemotherapy in clinical stage I nonseminoma, show a very low rate of relapse. As seminoma is even more chemosensitive than nonseminoma the relapse rate following one course of adjuvant BEP is expected to be very low, close to 1 %.
The overall aim is to investigate whether one course of adjuvant BEP have a lower relapse rate than one course of adjuvant carboplatin AUC7. In addition, it will be investigated if there is a difference in health related quality of life as well as acute and long-term toxicities from treatment.
Detailed Description
Short term overall survival is, regardless of treatment allocation, expected to be very close to 100 %. The primary outcome is relapse rate. The power of the study depends on the number of observed relapses. If the relapse rate in the adjuvant carboplatin group, the reference group, is lower than the anticipated 9 %, we need to include more patients to the study. Based on all previous published material on adjuvant treatment in clinical stage I seminoma it is not possible to precisely estimate the correct relapse rate until the median follow-up is four years. Consequently, we will estimate the relapse rate in the reference group close to the end of accrual. If the estimated relapse rate, and thus the number of relapses, is lower than the anticipated we will increase the sample size to make sure that the study meets the minimum required number of relapses in the reference group. A possible inclusion of more study participants does not compromise the Type I error rate of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Testicular Neoplasms, Seminoma
Keywords
Chemotherapy, adjuvant, Recurrence, Carboplatin, Bleomycin, Etoposide, Cisplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
348 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bleomycin-Etoposide-Cisplatin
Arm Type
Experimental
Arm Description
One course of adjuvant BEP.
Arm Title
Carboplatin
Arm Type
Active Comparator
Arm Description
One course of adjuvant carboplatin AUC7
Intervention Type
Drug
Intervention Name(s)
Bleomycin Etoposide and Cisplatin
Other Intervention Name(s)
BEP
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Carboplatin AUC7
Primary Outcome Measure Information:
Title
Relapse rate
Time Frame
10 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological diagnosis of unilateral seminoma testicular cancer, evaluating both size of tumor and invasion of the rete testis
Clinical stage I
Tumor size over 4 cm and/or stromal invasion of the rete testis by tumor cells
Normal value of alpha-fetoprotein (AFP) before orchiectomy. A stable, slightly elevated AFP as a normal value may be permitted.
Age ≥ 18 years and < 60 years
Adequate organ function defined as:
Serum aspartate transaminase (ALT) ≤ 1.5 x upper limit of normal (ULN). Total serum bilirubin ≤ 1.5 x ULN Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L Creatinine clearance > 50 ml/min (eGFR) All fertile patients should use safe contraception Written informed consent
Exclusion Criteria:
Signs of metastatic disease evaluated by CT thorax, abdomen and pelvis. Patients in need of restaging (see SWENOTECA IX) should not be included
Prior diagnosis of testicular cancer
Chronic pulmonary disorders giving a high risk of bleomycin induced toxicity (for example chronic obstructive pulmonary disease or lung fibrosis)
Cancer other than seminoma testicular cancer
Known hypersensitivity or contraindications for the study drugs
Serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
Medical, social, psychological conditions that could prevent adequate information and follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Torgrim Tandstad, MD PhD
Phone
+47 72826166
Email
torgrim.tandstad@stolav.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olof Ståhl, Md PhD
Organizational Affiliation
Skane University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Torgrim Tandstad, MD PhD
Organizational Affiliation
St Olavs University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institutt for kreftforskning og molekylær medisin, St Olavs Hospital
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torgrim Tandstad, md phd
Email
torgrim.tandstad@ntnu.no
Facility Name
St. Olavs University hospital HF
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torgrim Tandstad, MD
12. IPD Sharing Statement
Learn more about this trial
Adjuvant Bleomycin, Etoposide and Cisplatin (BEP) Versus Carboplatin in Stage I Seminomatous Testicular Cancer
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